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510(k) K832264

FITC GOAT ANTI-HUMAN IGG Y CHAIN by Gelco Diagnostics, Inc. — Product Code DEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1983
Date Received
June 30, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igg, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

Other clearances by Gelco Diagnostics, Inc.

  • K832256 — GOAT ANTI-HUMAN IMMUNOGLOBULINS- (October 31, 1983)
  • K832265 — FITC GOAT ANTI-HUMAN IGM H CHAIN (October 31, 1983)
  • K832267 — FITC GOAT ANTI-HUMAN LAMBA (October 31, 1983)
  • K832262 — FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS (October 31, 1983)
  • K832266 — FITC GOAT ANTI-HUMAN KAPPA AFFINITY (October 31, 1983)
  • K832260 — GOAT ANTI-HUMAN KAPPA AFFINITY (October 31, 1983)
  • K832263 — FITC GOAT ANTI-HUMAN IGA A CHAIN (October 31, 1983)
  • K832270 — GOAT ANTI-HUMAN LAMBA (October 31, 1983)
  • K832258 — GOAT ANTI-HUMAN IGG Y CHAIN SPECIFIC (October 31, 1983)
  • K832261 — GOAT ANTI-HUMAN LAMBA AFFINITY (October 28, 1983)

Other clearances for product code DEW

  • K050113 — TINA-QUANT IGG GEN.2 (February 8, 2005)
  • K040434 — ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2 (March 10, 2004)
  • K010617 — SPIFE IFE CALIBRATOR AND CONTROL KIT (March 15, 2001)
  • K993928 — WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD (January 18, 2000)
  • K993281 — K-ASSAY IGG (November 9, 1999)
  • K983221 — IGG (November 4, 1998)
  • K963974 — IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN (March 6, 1997)
  • K965108 — SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT (March 6, 1997)
  • K963868 — IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM) (February 10, 1997)
  • K962202 — QUANTEX IGG (September 26, 1996)